The European Commission approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK, or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
Predictive Oncology has partnered with Integra Therapeutics to pursue a novel method to enhance Integra Therapeutics’ ability to use gene editing for future cancer therapies.
Arsenal Biosciences Inc. advanced its lead product candidate into clinical manufacturing of its autologous integrated circuit T-cell therapy for platinum-resistant ovarian cancer. ArsenalBio’s work to develop multi-functional CAR-T cell therapies is enabled by Thermo Fisher’s Cell Therapy Systems portfolio of products, including the Gibco CTS Xenon Electroporation System and the Gibco CTS Rotea Counterflow Centrifugation System.
FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.
FDA granted accelerated approval to Zynyz (retifanlimab-dlwr) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
The American Cancer Society, in partnership with Winship Cancer Institute of Emory University will partner on a project that aims to significantly accelerate cancer research and improve patient outcomes.
FDA approved Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.
Prelude Therapeutics Inc. formed a clinical trial collaboration with BeiGene for future evaluation of its investigational CDK9 inhibitor, PRT2527, in combination with BeiGene’s BTK inhibitor, zanubrutinib, in hematologic malignancies.
FDA has approved an expanded indication for Eli Lilly and Company’s Verzenio (abemaciclib), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence.
FDA approved Roche’s VENTANA PD-L1 (SP263) assay as a companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with Libtayo (cemiplimab), based on the results of the Phase III EMPOWER-Lung study.
